The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 (one responsible source) to Fast-TrackDrugs and Biologics, LLC, 5 Paramus Court, North Potomac, MD 20878. The Naval Medical Logistics Command (NMLC) is seeking Contract Research Organization (CRO) sources with a large trajectory of research in Leishmaniasis for a collaborativeresearch effort to provide data-management, monitoring, and scientific writing support for the study titled "Evaluation of a Diagnostic Device, CL DetectTM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" in support of Naval Medical Research Unit Six (NAMRU-6), Parasitology Department, Ave.Venezuela Cdra 36 s/n , Bellavista - Callao - Peru.
The primary objective of the study is to determine the sensitivity and specificity of the FDA-cleared CL DetectTM Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of Leishmania species identified in Peru. The CL DetectTM Rapid Test is the trade name for the Cutaneous Leishmaniasis Rapid Diagnostic Device (LRDD). This acquisition requires the research project to provide data-management, monitoring, and scientific writing support for the study titled: "Evaluation of a Diagnostic Device, CL DetectTM Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru" (LRDD-PERU-02-NAMRU6.2015.0009). The CRO will perform activities such as developing studydocuments such as the Statistical Analysis Plan (SAP), Data-Management Plan, Monitoring Plan, Standard Operating Procedures (SOPs), Electronic-based Clinical Report Forms, Laboratory Manuals, and Logs (enrollment log, temperature log, device accountability log, temperature logs, etc.). The CRO will also provide onsiteand remote monitoring, training for all study personnel, provide the template and assist with the regulatory compliance of the Trial Master File, organize frequent teleconferences with all study teams, and create and update the study database. Finally the CRO will be responsible for the data analysis according to the Statistical Analysis Plan, write the Clinical Study Report (CSR) and prepare scientific reports in collaboration with the investigators. All activities must be carried out with the utmost adherence to all ethical and quality control standards. The contract will have a performance period of 12 months.
If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 to Fast-Track Drugs and Biologics, LLC, 5 Paramus Court, North Potomac, MD 20878.
This sources sought notice is not a request for competitive proposals and nosolicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and withconvincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.
Capability statements are due by 9:00AM Local Time, 29 January 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: email@example.com AND firstname.lastname@example.org.